FDA eases rules for imaging systems, fetal and maternal monitoring devices amid COVID-19
The US Food and Drug Administration (FDA) on Thursday issued guidance detailing relaxed policies for imaging systems and non-invasive fetal and maternal monitoring devices to increase availability of the devices amid the coronavirus disease (COVID-19) pandemic.The two guidelines, which take effect immediately, follow similar guidelines released in recent weeks covering diagnostic tests, ventilators, surgical apparel, face masks and respirators.
Imaging systems
In its enforcement policy for imaging systems, FDA says its goal is to increase the availability of X-ray, ultrasound and magnetic resonance imaging systems, as well as image analysis software, to reduce patient and healthcare provider exposure to COVID-19.
“Increasing the availability of mobile and portable systems may increase options to image patients inside and outside healthcare facilities, which could help to reduce the spread of COVID-19,” FDA writes.
Within the guidance, FDA explains that for the duration of the public health emergency, it does not intend to object to certain modifications made to imaging systems and image analysis software, including modifications to make imaging systems mobile or portable.
For image analysis software, FDA says companies can make modifications to add lung segmentation and measurement capabilities, to identify and evaluate findings related to COVID-19 and to aid in patient evaluation and monitoring using “quantitative metrics derived from patient images.”
FDA says companies that modify devices in line with the policy may do so without submitting a 510(k) or premarket approval application (PMA), so long as the device does not create an undue risk.
The guidance also lays out recommendations for validating changes made to devices, labeling, clinical decision support software and explains FDA’s policy for imaging system maintenance and servicing during the pandemic.
Fetal and maternal monitoring devices
FDA’s enforcement policy for non-invasive fetal and maternal monitoring devices is aimed at increasing access to devices that could reduce the need for in-clinic visits and reduce the burden on doctor’s offices and hospitals during the pandemic.
The guidance applies to two categories of devices, fetal dopplers intended for lay users and fetal and maternal monitoring devices used by healthcare providers in a home setting.
For the duration of the public health emergency, FDA says companies may make limited modifications to the indications, functionality, hardware and software of already-cleared devices without submitting a 510(k).
FDA says it does not plan to object to modifications that allow devices cleared for hospital use to be used in a home setting, modifications that allow for increased remote monitoring capabilities or modifications to make devices easier to transport.
FDA also provides validation and labeling recommendations for companies making modifications in line with the enforcement policy.
Enforcement Policy for Non-Invasive Fetal and Maternal Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
Enforcement Policy for Imaging Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency